Clinical Study on the Prevention of Driver Gene Negative Ib-IIIb Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This project adopts a prospective, multicenter, randomized controlled clinical study to investigate the treatment of TCM in postoperative patients with driver gene negative lung cancer, according to two phases of postoperative adjuvant therapy: (i) chemotherapy phase immunotherapy phase. In this study, 367 patients (183 in the control group and 184 in the trial group) will be observed over 4 years, and the quality of life, toxic effects and safety of this therapy will be investigated. This study will provide evidence-based evidence for the establishment and optimization of a new model of postoperative staged TCM with adjuvant chemo-immunotherapy for lung cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:
• Patients who underwent complete surgical resection (R0) with postoperative pathology confirmed as stage Ib to IIIb non-small cell lung cancer.
• Patients whose tissue or blood specimens tested negative for driver genes.
• Patients who received their first chemotherapy within 8 weeks postoperatively.
• Age ≥ 18 years ≤ 74 years, regardless of gender.
• Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2 points.
• absolute neutrophil value \>1.5×109 /L, platelet count \>80×109 /L, hemoglobin \>90mg/dL; no abnormal liver and kidney function test results.
• Understand and agree to participate in this study and sign the informed consent form.
Locations
Other Locations
China
YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
RECRUITING
Shanghai
Contact Information
Primary
Ling Xu, MD & PhD
xulq67@aliyun.com
86+021-65161782-1662
Time Frame
Start Date:2023-05-01
Estimated Completion Date:2027-06-30
Participants
Target number of participants:367
Treatments
Experimental: chemotherapy plus TCM 1&ICIs plusTCM2
Phase1： Chemotherapy：Proposed platinum-containing two-drug adjuvant chemotherapy, vincristine/paclitaxel/docetaxel/pemetrexed/gemcitabine plus cisplatin/carboplatin within 8 weeks after surgery, according to CSCO guidelines (2022).~TCM1 granules：oral granules, HeWeiYangXueFang , twice a day, every 21 days for 4 cycles.~Phase 2： One of the following agents may be selected after chemotherapy ：Nivolumab/Pembrolizumab/Durvalumab/Atezolizumab/ Camrelizumab/Dupilumab/Sintilimab/Tislelizumab.A total of 12 cycles will be performed or the patient will discontinue the drug due to intolerable toxic side effects.~TCM2 granules：oral granules, FeiPingFang , twice a day, every 21 days for 12 cycles.
Placebo_comparator: chemotherapy plus TCM 1 placebo&ICIs plus TCM2 placebo
Phase1： Chemotherapy：Proposed platinum-containing two-drug adjuvant chemotherapy, vincristine/paclitaxel/docetaxel/pemetrexed/gemcitabine plus cisplatin/carboplatin within 8 weeks after surgery, according to CSCO guidelines (2022).~Placebo1 granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect , twice a day, every 21 days for 4 cycles.~Phase 2：One of the following agents may be selected after chemotherapy：Nivolumab/Pembrolizumab/Durvalumab/Atezolizumab/ Camrelizumab/Dupilumab/Sintilimab/Tislelizumab.A total of 12 cycles will be performed or the patient will discontinue the drug due to intolerable toxic side effects.~Placebo2 granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, twice a day, every 21 days for 12 cycles.